Mailed Fecal Immunochemical Test Outreach Research Articles

Abstract A141: Exploring patient barriers and facilitators to colorectal cancer screening during the SARS-CoV-2 pandemic

Abstract Intro While there has been a national initiative to achieve 80% colorectal cancer (CRC) screening rates, not all population subgroups reach this target. Specifically, Latino populations have shown lower CRC screening rates compared to non-Latino White populations. Furthermore, the SARS-CoV-2 pandemic led to a decline in CRC screening uptake, particularly in Federally Qualified Health Centers (FQHCs). One large, urban FQHC, primarily serving Latino patients, has invested in stool-based, home-mailed CRC screening outreach. This FQHC serves as the site for the RESTORE study. Here, we describe patient-level barriers and facilitators to home fecal immunochemical test (FIT) screening throughout the COVID-19 pandemic. Methods Patients (n=15) were interviewed between August 2022 and May 2023. Interviews addressed health care utilization and CRC screening throughout the COVID-19 pandemic. Patient interviews were audio recorded and transcribed. A preliminary review of these interviews was conducted to assess patients’ use of telehealth as well as patients’ self-reported FIT completion. Results Participants’ average age was 58.5 years old; 53% identify as female; 66% report Spanish as their preferred language; and 80% identify as Latino. Ten patients (6 Spanish-speaking and 4 English-speaking) reported completing a home-mailed screening test. Among them, four emphasized the convenience of completing their CRC screening at home and found it beneficial to have wordless instructions included in their mailed FIT to guide them through the process. While these patients were able to complete their FIT, 3 reported that they never received their result. Of note, one of the Spanish speakers postponed FIT completion until in-person care resumed. Of the 4 Spanish-speaking patients who did not complete a FIT: 2 completed a colonoscopy, while the other 2 disposed of their FIT. The lone English speaker who did not complete FIT cited a fear of cancer as a barrier to screening. Patients who completed a colonoscopy described the procedure as easy; however, one patient experienced complications post-procedure. Telehealth visits were utilized by 80% of patients in 2020 and 73% in 2021, covering various health topics such as COVID-19 symptoms, infection, medication refills, and exam referral and results, with some patients citing convenience and quicker access to providers. Conclusions Throughout the SARS-CoV-2 period, patients continued to benefit from the FQHC’s mailed FIT outreach. As a novel primary care modality, patients reported completing clinical encounters via telehealth during the COVID-19 pandemic to discuss a range of health topics with a provider. To improve preparedness for future natural disasters, it is imperative to understand FQHC patients’ CRC screening experiences during this dynamic period. Citation Format: Anne Escaron, Robert Lara, Karina Ramirez, Adolfo Jacobo, Jennifer Schneider, Jennifer Rivelli, Crystal Gomez, Alexis Perez, Gloria Coronado. Exploring patient barriers and facilitators to colorectal cancer screening during the SARS-CoV-2 pandemic [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A141.

Factors Associated With Mailed Fecal Immunochemical Test Completion in an Integrated Academic-Community Healthcare System.

Mailed fecal immunochemical test (FIT) outreach is an effective strategy to increase colorectal cancer (CRC) screening. The aim of this study was to determine the patient-level, clinic-level, and geographic-level factors associated with CRC screening completion in a mailed FIT outreach program. This retrospective cohort study was conducted in the integrated healthcare system of University of Washington Medicine and included patients aged 50-75 years, who were due for CRC screening, and had a primary care encounter in the past 3 years. Eligible patients received mailed outreach that included a letter with information about CRC screening, FIT kit, and a prepaid return envelope. CRC screening and factors associated with completion were obtained from electronic health records and the CRC screening program database. Of the 9,719 patients who received mailed outreach, 29.6% completed FIT mailed outreach. The median FIT return time was 27 days (interquartile range 14-54). On multivariate analysis, patients with a higher area deprivation index, insured through Medicaid, living without a partner, and whose last primary care visit was >12 months ago were less likely to complete a FIT compared with their counterparts. Over a 12-month period, overall CRC screening across the health system increased by 2 percentage points (68%-70%). Mailed FIT outreach in an integrated academic-community practice was feasible, with 32% of invited patients completing CRC screening by FIT or colonoscopy, on par with published literature. Patient and geographic-level factors were associated with CRC screening completion. These data will inform additional interventions aimed to increase CRC screening participation in this population.

The Reach of Calls and Text Messages for Mailed FIT Outreach in the PROMPT Stepped-Wedge Colorectal Cancer Screening Trial.

Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening participation. We assessed the reach and effectiveness of adding notifications to mailed FIT programs. We conducted secondary analyses of a stepped-wedge evaluation of an enhanced mailed FIT program (n = 15 clinics). Patients were stratified by prior FIT completion. Those with prior FIT were sent a text message (Group 1); those without were randomized 1:1 to receive a text message (Group 2) or live phone call (Group 3). All groups were sent automated phone call reminders. In stratified analysis, we measured reach and effectiveness (FIT completion within 6 months) and assessed patient-level associations using generalized estimating equations. Patients (n = 16,934; 83% Latino; 72% completed prior FIT) were reached most often by text messages (78%), followed by live phone calls (71%), then automated phone calls (56%). FIT completion was higher in patients with prior FIT completion versus without [44% (Group 1) vs. 19% (Group 2 + Group 3); P < 0.01]. For patients without prior FIT, effectiveness was higher in those allocated to a live phone call [20% (Group 3) vs. 18% (Group 2) for text message; P = 0.04] and in those who personally answered the live call (28% vs. 9% no call completed; P < 0.01). Text messages reached the most patients, yet effectiveness was highest in those who personally answered the live phone call. Despite the broad reach and low cost of text messages, personalized approaches may more successfully boost FIT completion.

Methods for scaling up an outreach intervention to increase colorectal cancer screening rates in rural areas

BackgroundMailed fecal immunochemical test (FIT) outreach and patient navigation are evidence-based practices shown to improve rates of colorectal cancer (CRC) and follow-up in various settings, yet these programs have not been broadly adopted by health systems and organizations that serve diverse populations. Reasons for low adoption rates are multifactorial, and little research explores approaches for scaling up a complex, multi-level CRC screening outreach intervention to advance equity in rural settings.MethodsSMARTER CRC, a National Cancer Institute Cancer Moonshot project, is a cluster-randomized controlled trial of a mailed FIT and patient navigation program involving 3 Medicaid health plans and 28 rural primary care practices in Oregon and Idaho followed by a national scale-up trial. The SMARTER CRC intervention combines mailed FIT outreach supported by clinics, health plans, and vendors and patient navigation for colonoscopy following an abnormal FIT result. We applied the framework from Perez and colleagues to identify the intervention’s components (including functions and forms) and scale-up dissemination strategies and worked with a national advisory board to support scale-up to additional organizations. The team is recruiting health plans, primary care clinics, and regional and national organizations in the USA that serve a rural population. To teach organizations about the intervention, activities include Extension for Community Healthcare Outcomes (ECHO) tele-mentoring learning collaboratives, a facilitation guide and other materials, a patient navigation workshop, webinars, and individualized technical assistance. Our primary outcome is program adoption (by component), measured 6 months after participation in an ECHO learning collaborative. We also assess engagement and adaptations (implemented and desired) to learn how the multicomponent intervention might be modified to best support broad scale-up.DiscussionFindings may inform approaches for adapting and scaling evidence-based approaches to promote CRC screening participation in underserved populations and settings.Trial registrationRegistered at ClinicalTrials.gov (NCT04890054) and at the NCI’s Clinical Trials Reporting Program (CTRP no.: NCI-2021–01032) on May 11, 2021.

Implementing an Organized Colorectal Cancer Screening Program: Lessons Learned From an Academic–Community Practice

IntroductionThe effectiveness of mailed fecal immunochemical test (FIT) outreach might be enhanced through an organized colorectal cancer (CRC) screening program, yet published real-world experiences are limited. We synthesized the process of implementing a CRC screening program which used mailed FIT outreach in a large integrated academic-community practice. Materials and MethodsData from a pilot mailed FIT program were shared with healthcare system leadership which inspired the creation of a cross-institutional organized CRC Screening Program. In partnership with a centralized Population Health Team and Primary Care, we defined: 1) the institutional approach to CRC screening, 2) the target population and method for screening, 3) the team responsible for implementation, 4) the healthcare team responsible for decisions and care, 5) a quality assurance structure, and 6) a method for identifying cancer occurrence. ResultsThe Fred Hutch/UW Medicine Population Health CRC Screening Program began in September 2021. The workflow for mailed FIT outreach included a mailed postcard, a MyChart message from the patient's primary care provider (PCP), a FIT kit with a letter signed by the PCP and program director, and up to three bi-weekly reminders. Patients without a colonoscopy 3 months after an abnormal FIT result received navigation through the program. In the first program year, we identified 9,719 patients eligible for outreach and in an intention to treat analysis, 32% of patients completed CRC screening by FIT or colonoscopy. ConclusionsReal-world experiences detailing how to implement organized CRC screening programs might increase adoption. In our experience, broadly disseminating pilot data, early institutional support, robust data management and strong cross-departmental relationships were critical to successfully implementing a CRC screening program that benefits all patients.

Effectiveness and Cost of an Enhanced Mailed Fecal Test Outreach Colorectal Cancer Screening Program: Findings from the PROMPT Stepped-Wedge Trial.

Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening rates, yet little is known about how to optimize these programs for effectiveness and cost. PROMPT was a pragmatic, stepped-wedge, cluster-randomized effectiveness trial of mailed FIT outreach. Participants in the standard condition were mailed a FIT and received live telephone reminders to return it. Participants in the enhanced condition also received a tailored advance notification (text message or live phone call) and two automated phone call reminders. The primary outcome was 6-month FIT completion; secondary outcomes were any colorectal cancer screening completion at 6 months, implementation, and program costs. The study included 27,585 participants (80% ages 50-64, 82% Hispanic/Latino; 68% preferred Spanish). A higher proportion of enhanced participants completed FIT at 6 months than standard participants, both in intention-to-treat [+2.8%, 95% confidence interval (CI; 0.4-5.2)] and per-protocol [limited to individuals who were reached; +16.9%, 95% CI (12.3-20.3)] analyses. Text messages and automated calls were successfully delivered to 91% to 100% of participants. The per-patient cost for standard mailed FIT was $10.84. The enhanced program's text message plus automated call reminder cost an additional $0.66; live phone calls plus an automated call reminder cost an additional $10.82 per patient. Adding advance notifications and automated calls to a standard mailed FIT program boosted 6-month FIT completion rates at a small additional per-patient cost. Enhancements to mailed FIT outreach can improve colorectal cancer screening participation. Future research might test the addition of educational video messaging for screening-naïve adults.

Implementing an enhanced mailed FIT program to improve CRC screening at a federally qualified health center: experiences of patients and staff.

Colorectal cancer (CRC) is a leading cause of cancer death in the USA. Screening programs in federally qualified health centers (FQHCs) are essential to reducing CRC-related mortality and morbidity among underserved populations. Centralized, population-based mailed fecal immunochemical test (FIT) programs can improve CRC screening rates, but barriers to implementation remain. We qualitatively explored barriers and facilitators to implementation of a mailed FIT program at a large, urban FQHC that employed advance notification "primers" (live calls and texts) and automated reminders. We interviewed 25 patients and 45 FQHC staff by telephone about their experience with the program. Interviews were transcribed, coded, and content analyzed using NVivo.12. Patients and staff found advance notifications conveyed through live phone calls or text messages to be acceptable and motivational for FIT completion. Live phone primers were helpful in addressing patients' questions and misconceptions about screening, particularly for patients new to screening. Advance notifications sent by text were considered timely and useful in preparing patients for receipt of the FIT. Barriers to implementation included lack of receipt of primers, reminders, or the mailed FIT itself due to inaccurate patient contact information within the FQHC medical record; lack of systems for documenting mailed FIT outreach to coordinate with clinical care; and lack of local caller identification for primers and reminders. Our findings demonstrate that an enhanced mailed FIT program using primers and reminders was acceptable. Our findings can help other FQHCs implement and optimize their mailed FIT programs.

Reach and effectiveness of a centralized navigation program for patients with positive fecal immunochemical tests requiring follow-up colonoscopy

Completion rates for follow-up colonoscopies after an abnormal fecal immunochemical test (FIT) are suboptimal in federally qualified health center (FQHC) settings. We implemented a screening intervention that included mailed FIT outreach to North Carolina FQHC patients from June 2020 to September 2021 and centralized patient navigation to support patients with abnormal FITs in completing follow-up colonoscopy. We evaluated the reach and effectiveness of navigation using electronic medical record data and navigator call logs detailing interactions with patients. Reach assessments included the proportion of patients successfully contacted by phone and who agreed to participate in navigation, intensity of navigation provided (including types of barriers to colonoscopy identified and total navigation time), and differences in these measures by socio-demographic characteristics. Effectiveness outcomes included colonoscopy completion, timeliness of follow-up colonoscopy (i.e., within 9 months), and bowel prep adequacy. Among 514 patients who completed a mailed FIT, 38 patients had an abnormal result and were eligible for navigation. Of these, 26 (68%) accepted navigation, 7 (18%) declined, and 5 (13%) could not be contacted. Among navigated patients, 81% had informational needs, 38% had emotional barriers, 35% had financial barriers, 12% had transportation barriers, and 42% had multiple barriers to colonoscopy. Median navigation time was 48.5 min (range: 24–277 min). Colonoscopy completion differed across groups – 92% of those accepting navigation completed colonoscopy within 9 months, versus 43% for those declining navigation. We found that centralized navigation was widely accepted in FQHC patients with abnormal FIT, and was an effective strategy, resulting in high colonoscopy completion rates.

Individuals with a Family History of Colorectal Cancer Warrant Tailored Interventions to Address Patient-Reported Barriers to Screening.

Population health interventions to increase colorectal cancer (CRC) screening rates often exclude individuals with a family history of CRC, and interventions to increase screening in this high-risk group are rare. We aimed to determine the screening rate and barriers and facilitators to screening in this population to inform interventions to increase screening participation. We performed a retrospective chart review and cross-sectional survey of patients excluded from mailed fecal immunochemical test (FIT) outreach due to a family history of CRC in a large health system. We used Chi-square, Fisher's exact, and Student's t-tests to compare demographic and clinical characteristics of individuals overdue and not overdue for screening. We then administered a survey (mailed and telephone) to overdue patients to assess barriers and facilitators to screening. There were 296 patients excluded from mailed FIT outreach and 233 had a confirmed family history of CRC. Screening participation was low (21.9%), and there were no significant demographic or clinical differences between those overdue and not overdue for screening. There were 79 survey participants. Major patient-reported barriers to screening colonoscopy were patient forgetfulness (35.9%), fear of pain during colonoscopy (17.7%), and hesitancy about bowel preparation (29.4%). To facilitate screening colonoscopy, patients recommended reminders (56.3%), education about familial risk (50%), and colonoscopy education (35.9%). Patients with a family history of CRC that are excluded from mailed FIT outreach have low screening rates and report multiple mutable barriers to screening. They warrant targeted efforts to increase screening participation.

Neighborhood socioeconomic status and the effectiveness of colorectal cancer screening outreach with mailed fecal immunochemical tests within a safety net healthcare system in San Francisco, CA: A subgroup analysis of a randomized controlled trial

Neighborhood context shapes opportunities and barriers for residents to access healthcare and cancer screening. Neighborhood socioeconomic status (nSES) is associated with disparities in colorectal cancer (CRC) screening, but the extent to which the effectiveness of specific screening interventions vary by nSES has not been studied. The original trial conducted in San Francisco, CA from 2016 to 2017 randomly assigned patients eligible for CRC screening either to a multicomponent intervention including advanced notification, mailed fecal immunochemical test (FIT) kits and reminders or to a control group receiving usual care. For the nSES analysis addresses for 9699 patients were geocoded and stratified by city-wide nSES quintile (Q1 lowest, Q5 highest) using an established index at the census tract level. Compared to usual care, the outreach intervention improved FIT test completion at one year (58.7% vs 38.4%; OR 2.32 [2.14, 2.52]) but its effectiveness did not vary substantially by nSES quintile (adjusted OR Q1 2.64 [2.30, 3.04]; Q2 2.43 [2.04, 2.90]; Q3 2.31 [1.84, 2.89]; Q4 2.47 [1.86, 3.28]; Q5 2.64 [1.83, 3.81]; Wald test for interaction p = 0.87). The implementation of mailed FIT outreach has the potential to increase CRC screening completion without leading to disparities in screening related to nSES (ClinicalTrials.gov NCT02613260).

S255 Assessing the Impact of a Multi-Component Health System Intervention to Address Low Colorectal Cancer Screening Participation in Patients With a Family History of Colorectal Cancer

Introduction: In the United States, 3-10% of individuals have a family history of colorectal cancer (CRC). Population health strategies to increase CRC screening often exclude these individuals, and interventions to increase screening participation in this high-risk group are rare. We designed and implemented a multi-component health system intervention to increase CRC screening uptake among individuals with a family history of CRC that were excluded from mailed fecal immunochemical test (FIT) outreach in our health system. Methods: The study was performed in a large academic medical center with biannual mailed FIT outreach for individuals at average-risk for CRC. We included patients who did not receive mailed FIT outreach in 2021 due to a family history of CRC. We excluded patients with a personal history of inflammatory bowel disease, colectomy, or CRC. The intervention included both primary care provider (PCP) and patient components. The PCP component was sent via the electronic health record (EHR) and included CRC screening guidelines for patients with a family history of CRC and a pended colonoscopy order for each patient overdue for screening. The patient component was delivered via the EHR patient portal and a mailed letter and included education about familial risk and colonoscopy, and a prompt to schedule a colonoscopy. Preliminary outcomes were measured 2-months post-intervention and were whether: (1) the PCP signed the pended colonoscopy order and (2) the patient scheduled colonoscopy. We used descriptive statistics to describe the study cohort and paired t-tests to compare the study outcomes pre- and post-intervention. The primary outcome of colonoscopy completion will be measured 6 months post-intervention. Results: 152 patients received the intervention. The mean age was 61.3 years (s.d 7.0), 32.9% were male, and 42.1% were non-Hispanic White (Table). Colonoscopy orders increased from 32 (21.1%) to 92 (60.5%) from pre- to post-intervention (p< 0.0001) (Figure). Colonoscopies scheduled increased from 0 to 9 (5.9%) (p=0.002). Conclusion: We designed and evaluated the preliminary results of a health system intervention that aims to increase screening participation among individuals with a family history of CRC. There was a significant increase in both colonoscopies ordered and colonoscopies scheduled. This study demonstrates a successful population health strategy to increase provider and patient intention to screen in this high-risk population.Figure 1.: Screening colonoscopies ordered and screening colonoscopies scheduled pre- intervention versus post- intervention, n= 152 Table 1. - Intervention population characteristics, n= 152 Patient Characteristic Study Population (n=152) Age [years, mean (SD)] 61.3 (7.0) Male Sex [n (%)] 50 (32.9) White Race [n (%)] 72 (47.4) Non-Hispanic Ethnicity [n (%)] 116 (76.3) Private Insurance [n (%)] 149 (98.0) Married [n (%)] 83 (54.6) English Language Preference [n (%)] 147 (96.7) Social Vulnerability Index [median (IQR)] 25.9 (11.8-47.8) Current or Former Tobacco Use Disorder [n (%)] 38 (25.0) Current or Former Alcohol Use Disorder [n (%)] 13 (8.6) Body Mass Index ≥ 25 [n (%)] 100 (66.2) Hemoglobin A1c ≥ 5.7 [n (%)] 75 (52.8) Family Members with Documented CRC [median (IQR)] 1 (1-1) 1st Degree Family Members with Documented CRC [median (IQR)] 1 (1-1) Years since Last PCP Visit [median (IQR)] 1.01 (0.75-1.62) Years since Last GI Visit [median (IQR)] 2.3 (2.5-9.2) Breast Cancer Screening Up-To-Date [n (%)] 47 (47) Cervical Cancer Screening Up-To-Date [n (%)] 61 (83.6)

Cost-effectiveness of mt-sDNA versus mailed FIT outreach for Medicare Advantage enrollees using the CRC-AIM microsimulation model.

e18827 Background: Despite proven effectiveness in reducing colorectal cancer (CRC) cases, screening for CRC remains underutilized, including those enrolled in Medicare Advantage. A mailed fecal immunochemical test (FIT) outreach program may increase CRC screening adherence. This study examined the cost-effectiveness of stool-based tests (FIT and multi-target stool DNA [mt-sDNA]), with FIT offered via a mailed outreach program, in a Medicare Advantage population. Methods: The validated CRC-AIM microsimulation model was used to simulate the costs and clinical outcomes of 2 million average-risk individuals, free of diagnosed CRC at age 40, who initiated CRC screening at age 65. Annual mailed FIT outreach and triennial mt-sDNA were assessed. Test sensitivity and specificity inputs were based on the 2021 United States Preventative Services Task Force modeling study. FIT outreach program cost ($25.92) and direct costs for screening tests, colonoscopies (COLs), complications, and CRC care were included. The model employed a lifetime horizon, 3% discount rates, and a Medicare Advantage perspective. The primary analysis used published real-world adherence rates for stool-based tests and follow-up COLs (FIT/COL: 29%/53%; mt-sDNA/COL: 69.8%/71.5%). Secondary analyses assumed 100% adherence for stool-based tests and/or follow-up COLs and 20% higher than primary analysis for FIT and the corresponding follow-up COLs. Results: In the primary analysis, mt-sDNA had the greatest life-years gained (LYG), incidence reduction (IR), and mortality reduction (MR) and was cost-effective at a willingness-to-pay threshold of $50,000/QALY compared to mailed FIT outreach (Table). This was true when 100% adherence was assumed for follow-up COL and when FIT had 20% higher adherence than the primary analysis. mt-sDNA had 64-129% greater LYG, 79-150% greater IR, and 68-146% greater MR than mailed FIT outreach. When assuming 100% adherence for both screening test and follow-up COL, mt-sDNA was dominated by mailed FIT outreach. Conclusions: Adherence to CRC screening modality and follow-up COL greatly impacts clinical and cost-effectiveness outcomes. Future analysis should consider evidence-based, health plan-specific data to accurately reflect outcomes that aid in payer decision making.[Table: see text]

Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates

Colorectal cancer (CRC) screening reduces CRC mortality; however, screening rates remain well below the national benchmark of 80%. To determine whether an electronic primer message delivered through the patient portal increases the completion rate of CRC screening in a mailed fecal immunochemical test (FIT) outreach program. In this randomized clinical quality improvement trial at the University of California, Los Angeles Health of 2339 patients enrolled in a FIT mailing program from August 28, 2019, to September 20, 2020, patients were randomly assigned to either the control or intervention group, and the screening completion rate was measured at 6 months. Participants were average-risk managed care patients aged 50 to 75 years, with a valid mailing address, no mailed CRC outreach in the previous 6 months, and an active electronic health record (EHR) patient portal who were due for CRC screening. Data were analyzed on an intention-to-treat basis. Eligible patients were randomly assigned to receive either (1) the standard FIT mailed outreach (control group) or (2) the standard FIT mailed outreach plus an automated primer to notify patients of the upcoming mailed FIT sent through the electronic patient portal (intervention group). The primary outcome was the screening completion rate (ie, returning the FIT). Secondary outcomes were (1) were the time to CRC screening from the FIT mailing date, (2) screening modality completed, and (3) the effect of opening the electronic primer on screening completion rate. The study included 2339 patients (1346 women [57.5%]; mean [SD] age, 58.9 [7.5] years). The screening completion rate was higher in the intervention group than in the control group (37.6% [445 of 1182] vs 32.1% [371 of 1157]; P = .005). The time to screening was shorter in the intervention group than in the control group (adjusted hazard ratio, 1.24; 95% CI, 1.08-1.42; P = .003). The proportion of each screening test modality completed was similar in both groups. In a subanalysis of the 900 of 1182 patients (76.1%) in the intervention group who opened the patient portal primer message, there was a 7.3-percentage point (95% CI, 2.3-12.4 percentage points) increase in CRC screening (local mean treatment effect; P = .004). Implementation of an electronic patient portal primer message in a mailed FIT outreach program led to a significant increase in CRC screening and improvement in the time to screening completion. The findings provide an evidence base for additional refinements to mailed FIT outreach quality improvement programs in large health systems. ClinicalTrials.gov Identifier: NCT05115916.

Centralized colorectal cancer screening outreach and patient navigation for vulnerable populations in North Carolina: study protocol for the SCORE randomized controlled trial

BackgroundAlthough colorectal cancer (CRC) screening is effective in reducing CRC mortality, screening rates in vulnerable populations served by community health centers (CHCs) remain below national targets. CHCs in North Carolina are challenged to reach CRC screening targets as they tend to be under-resourced, have limited capacity to implement and sustain population health interventions, and typically operate independently from one another and from regional colonoscopy providers. The Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE) project is designed to address barriers to CRC screening in partnership with CHCs by implementing a multilevel intervention that includes centralized support infrastructure for mailed fecal immunochemical test (FIT) outreach and patient navigation to follow-up colonoscopy. This paper describes protocols for the SCORE implementation trial.MethodsWe will conduct a type 2 hybrid effectiveness-implementation trial that will assess effectiveness at increasing CRC screening and follow-up rates while also assessing implementation outcomes. The planned trial sample will include 4000 CHC patients who are at average CRC risk and due for screening. Participants will be randomized 1:1 to receive either usual care or a multilevel intervention that includes mailed FIT outreach and patient navigation support to follow-up colonoscopy for those with abnormal FIT. The primary effectiveness outcome is completion of any CRC screening test at six months after randomization. We will also conduct a multilevel assessment of implementation outcomes and determinants.DiscussionThis hybrid effectiveness-implementation trial will evaluate the effectiveness and implementation of an intervention that provides centralized infrastructure for mailed FIT screening and patient navigation for CHCs that operate independently of other healthcare facilities. Findings from this research will enhance understanding of the effectiveness of a centralized approach and factors that determine successful implementation in vulnerable patient populations.Trial registrationThe trial was registered on May 28, 2020, at ClinicalTrials.gov (identifier NCT04406714).

Increased Colorectal Cancer Screening Sustained with Mailed Fecal Immunochemical Test Outreach

Reports of mailed fecal immunochemical test (FIT) outreach effectiveness over time are minimal. We aimed to better evaluate a mailed FIT program with longitudinal metrics. A total of 10,771 patients aged 50 to 75 years not up-to-date with colorectal cancer screening were randomized to intervention or usual care. The intervention arm received an advanced notification call and informational postcard prior to a mailed FIT. Usual care was at the discretion of the primary care provider. Patients were followed for up to 2.5 years. The primary outcome was the difference in cumulative proportion of completed FIT screening between arms. Screening was further examined with the proportion of time up-to-date, consistency of adherence, and frequency of abnormal FIT. The cumulative proportion of FIT completion was higher in the outreach intervention (73.2% vs 55.1%; P < .001). The proportion of time covered by screening was higher in the intervention group (46.8% vs 27.3%; Δ19.6%; 95% confidence interval, 18.2%-20.9%). Patients assigned to FIT outreach were more likely to consistently complete FITs (2 completed of 2 offered) (50.1% vs 21.8%; P < .001). However, for patients who did not complete the FIT during the first cycle, only 17.1% completed a FIT during the second outreach cycle. The number and overall proportion of abnormal FIT was significantly higher in the outreach intervention (6.9% Outreach vs 4.1% Usual Care; P < .01). Organized mailed FIT outreach significantly increased colorectal cancer screening over multiple years in this safety-net health system. Although mailing was overall effective, the effect was modest in patients who did not complete FIT in first cycle of intervention. (ClincialTrials.gov, NCT02613260).

Factors Influencing Implementation of a Colorectal Cancer Screening Improvement Program in Community Health Centers: an Applied Use of Configurational Comparative Methods.

Evidence-based programs such as mailed fecal immunochemical test (FIT) outreach can only affect health outcomes if they can be successfully implemented. However, attempts to implement programs are often limited by organizational-level factors. As part of the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) pragmatic trial, we evaluated how organizational factors impacted the extent to which health centers implemented a mailed FIT outreach program. Eight health centers participated in STOP CRC. The intervention consisted of customized electronic health record tools and clinical staff training to facilitate mailing of an introduction letter, FIT kit, and reminder letter. Health centers had flexibility in how they delivered the program. We categorized the health centers' level of implementation based on the proportion of eligible patients who were mailed a FIT kit, and applied configurational comparative methods to identify combinations of relevant organizational-level and program-level factors that distinguished among high, medium, and low implementing health centers. The factors were categorized according to the Consolidated Framework for Implementation Research model. FIT tests were mailed to 21.0-81.7% of eligible participants at each health center. We identified a two-factor solution that distinguished among levels of implementation with 100% consistency and 100% coverage. The factors were having a centralized implementation team (inner setting) and mailing the introduction letter in advance of the FIT kit (intervention characteristics). Health centers with high levels of implementation had the joint presence of both factors. In health centers with medium levels of implementation, only one factor was present. Health centers with low levels of implementation had neither factor present. Full implementation of the STOP CRC intervention relied on a centralized implementation team with dedicated staffing time, and the advance mailing of an introduction letter. ClinicalTrials.gov Identifier: NCT01742065 Registered 05 December 2012-Prospectively registered.

Advanced Notification Calls Prior to Mailed Fecal Immunochemical Test in Previously Screened Patients: a Randomized Controlled Trial.

Phone calls as part of multimodal fecal immunochemical test (FIT) outreach are effective but resource-intensive. Previous studies of advanced notification calls before FIT mailing have not differentiated patients' prior screening status. To determine the effectiveness of a phone call preceding mailing of a FIT kit on test completion rate for patients who have completed a prior FIT. Randomized controlled trial nested within a larger study. All patients were assigned to receive organized mailed FIT outreach in the larger study. Patients in a safety-net health setting ages 50-75 years old with a previously negative FIT. Patients were assigned to either receive an advanced notification phone call or no phone call preceding a mailed FIT kit. Both groups received an informational postcard prior to the mailed FIT. The primary outcome was FIT completion rate at 1 year. The secondary outcomes were FIT completion rates at 60, 90, and 180 days, rates stratified by demographic subgroups, and rates according to outcome of the phone call. A total of 1645 patients were assigned to advanced notification calls and 1595 were assigned to no call preceding the FIT mailing. Although FIT completion rate was higher at day 60 (55.5% vs. 50.8%, p < 0.01), an advanced notification call did not significantly improve FIT completion at 1 year (70.9% vs. 69.9%, p = 0.52). Of the patients assigned to receive an advanced notification call, 90.5% were spoken with or left a voicemail; patients who were spoken with were more likely to complete a FIT at 1 year compared with patients who were only left a voicemail or could not be left a voicemail (79.9% vs. 69.2% vs. 49.6%, p < 0.01). Advanced notification phone calls prior to FIT mailing did not improve rates at 1 year for patients with a previously negative FIT.

Randomized Controlled Trial of Advance Notification Phone Calls vs Text Messages Prior to Mailed Fecal Test Outreach

BACKGROUND & AIMS:Mailing fecal immunochemical test (FITs) to individuals who are due for screening (mailed FIT outreach) increases colorectal cancer (CRC) screening. Little is known about how phone-based advance notifications (primers) affect the effectiveness of mailed FIT outreach programs.METHODS:We performed a prospective study of patients at a large urban health center, 50–75 years old and due for screening, with no record of a prior FIT. Participants were randomly assigned to groups that received a live phone call primer (n = 1203) or a text message primer (n = 1622), from June through December 2018. The participants were then mailed a FIT kit, followed by 2 automated calls, and live reminder calls delivered by the care team. The main outcome was completion of FIT within 3 months of assignment to the live phone call or text message group.RESULTS:Participants had a FIT completion rate of 16.8%, a mean age of 58 years, and 80% were Latino. In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%–6.2%). Between-group differences increased to 7.3% points (95% CI, 3.6%–11.0%) in the per-protocol analysis of 2144 participants reached by the text message (1320/1622, 81%), live call (438/1203, 36%), or voice message (386/1203, 32%). This rate increased to 14.9% points (95% CI; 9.6%–20.1%) in the per-protocol analysis of 1758 participants reached by the text message or reached by the live call.CONCLUSIONS:In a randomized trial, advance notification live phone calls outperformed text messages in prompting health center patients who had not previously completed a FIT to complete a mailed FIT. Clinicaltrials.gov no: NCT03167125

Screening and Surveillance Colonoscopy and COVID-19: Avoiding More Casualties

Screening and Surveillance Colonoscopy and COVID-19: Avoiding More Casualties

Abstract C129: Do phone-based discussions about the importance of colorectal cancer screening delivered before a fecal immunochemical test (FIT) mailing improve return rates?

Abstract Patients who have never completed a fecal immunochemical test (FIT) may benefit from phone-based discussions about the importance of colon cancer screening before receiving the FIT in the mail. Colorectal cancer is the second-leading cause of cancer death in the United States, and screening rates are disproportionately low among Latinxs. In 2015, only 63% of eligible adults, and 50% of Latinxs, were up to date with colorectal cancer screening recommendations. Mailed FIT outreach programs have been shown to improve colorectal cancer screening rates in community health centers, with improvements ranging from 22% – 45%. Despite the widespread use of primers and reminders for mailed FIT outreach programs, data are sparse on how these communications influence FIT completion rates. Data from our previous evaluation of mailed FIT outreach showed that adults who have never completed a FIT have a much lower FIT return rate than adults who have (17.1 vs 45.1; p &amp;lt; 0.01). As part of the Participatory Research to Advance Colon Cancer Prevention (PROMPT), which involved a partnership with a Los Angeles-based community health center that provides medical services to 300,000 patients annually (82% are Latinx), we tested whether patients who had never completed a FIT could benefit from phone-based discussions about the importance of colorectal cancer screening. Eligible patients were 50-74, due for their screening, and assigned to a wedge 1 clinic (n = 8 clinics; 6,872 patients). A total of 2,825 patients had no electronic health record evidence of having completed a prior FIT. These patients were randomized to receive the text primer (n = 1,622) or live call primer (n = 1,203). All live primer calls were delivered by bilingual health education staff trained by the research team. Patients were then mailed a FIT kit with an introductory letter and wordless instructions on completing the FIT, followed by two automated phone call reminders and live reminder calls delivered by the care team. We used logistic regression to compare the effectiveness of live call vs text message primers on FIT completion rates 3 months after the FIT mailing. Randomized patients (who had never completed the FIT) had a mean age of 58 years (SD, 6.0), 51% were female, and 80% Latinx. In the text primer arm, the overall FIT completion rate was 14.7%, and 14.6% among those who were successfully delivered the text primer. In the live call arm, the overall FIT completion rate was 18.8%, and 30.0% among those who had a discussion with health education staff. Controlling for age, preliminary analyses indicate that patients who received a live call were 1.35 times more likely to complete a FIT within 3 months of the mailing than those who received a text message primer (OR=1.35 [1.10, 1.64]). Live phone call primers, delivered before the FIT is mailed, boost screening rates among those who have never completed a FIT. Note: This abstract was not presented at the conference. Citation Format: Jamie Thompson, Denis Nyongesa, Amanda Petrik, Melissa Castillo, Gloria Coronado. Do phone-based discussions about the importance of colorectal cancer screening delivered before a fecal immunochemical test (FIT) mailing improve return rates? [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr C129.